6. Subject has laboratory values that are greater than 2 times the upper limit of normal (with the exception of white blood cell [WBC] differential values). Enrollment of subjects with laboratory values that are between 1 and 2 times the upper limit of normal (ULN), or below the lower limit of normal, or white blood cells (WBC) differential > 2 x ULN , will be left to the investigator's discretion (no increased risk of participation in study based upon judgment of the investigator).